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Notice under subsections 42ZCZS/42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations)

The delegates of the Secretary to the Department of Health hereby give notice of delegates' final decisions for amending the Poisons Standard (commonly referred to as the Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP) under subsections 42ZCZS/42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations). This notice also provides the reasons for each decision and the date of effect (implementation date) of the decision.

The delegates' final decisions and reasons relate to:

scheduling proposals referred to the November 2016 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#18);

scheduling proposals referred to the November 2016 meeting of the Advisory Committee on Medicines Scheduling (ACMS#19);

scheduling proposals referred to the November 2016 meeting of the Joint Advisory Committee on Chemicals and Medicines Scheduling (Joint ACCS-ACMS#14)

scheduling proposals considered as delegate-only matters, i.e. not referred to an expert advisory committee.

Scheduling proposals referred to the expert advisory committees.

Pre-meeting public notice

On 4 August 2016 and 22 September 2016, under subsection 42ZCZK of the Therapeutic Goods Regulations 1990 (the Regulations), the delegate published a pre-meeting public notice on the TGA website which specified the proposed amendments to the current Poisons Standard and invited public comment.

The pre-meeting consultation periods were each open for public comment for 20 business days and closed on 1 September 2016 and 20 October 2016.

Interim decisions

November 2016 ACCS#18, ACMS#19 and Joint ACCS-ACMS#14.

On 2 February 2017, in accordance with subsection 42ZCZN of the Regulations, the delegate made an interim decision on an application and under subsection 42ZCZP of the Regulations, the interim decision and the reasons for the decision was published on TGA website. Further submissions were also invited from the applicants and parties who made valid pre-meeting submissions. The inivitation to make submissions was open for 10 business days and closed on 16 February 2017.

Final decisions

In accordance with subsection 42ZCZR of the Regulations, if a delegate makes an interim decision on an application, the delegate may make a final decision either, confirming, varying or setting aside the interim decision, but only after considering any valid submissions received in response to the interim decisions.

Matters not referred to an advisory committee

According to subsections 42ZCZT/42ZCZU of the Regulations a delegate may decide not to refer a scheduling proposal to an expert advisory committee for advice and instead may make a delegate-only decision. When deciding not to refer a matter to a committee, the delegate considers the scheduling guidelines as set out in the Scheduling Policy Framework for Chemicals and Medicines (SPF, 2015), available at SPF, February 2015.

Publishing of the amendments to the Poisons Standard

The amendments to the Schedules, Appendices or other parts of the Poisons Standard are published electronically on the Federal Register of Legislation (FRL) as amendments to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) prior to the date of effect (implementation date) of the final decisions. Further information, including links to the Poisons Standard on FRL, is available at SUSMP.

Table of contents

Part A - Final decisions on matters referred to an expert advisory committee